NCT01698619

Brief Summary

We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

September 1, 2012

Enrollment Period

4 months

First QC Date

September 27, 2012

Last Update Submit

October 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in Oxygen Delivery

    Unit: ml/min baseline measure will be obtained at sea level

    daily, up to 18 days

Secondary Outcomes (1)

  • Changes from baseline in Hemoglobin Concentration

    daily, up to 18 days

Other Outcomes (1)

  • Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output

    daily, up to 18 days

Study Arms (1)

Climbers on Mount Aconcagua

The Cohort consists of volunteers climbing Mount Aconcagua.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy volunteers taking part in an expedition to Mount Aconcagua

You may qualify if:

  • No acute or chronic disease
  • Body mass index : 20 - 30

You may not qualify if:

  • Any preexisting disease that has a potential impact on physical performance such as:
  • pulmonary
  • cerebral
  • muscular
  • cardiac
  • vascular - diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 3, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-09

Locations